SIROS DELIVERY SET
Received Nov 4, 2025 · Event occurred Oct 6, 2025
Report 9710358-2025-00016 · MDR key 23468698
Device
Generic name
System, Applicator, Radionuclide, Manual
Manufacturer
Sirtex Medical Pty LimitedModel number
SIR-10300Lot number
11428101
Product problems
- Complete Blockage
- Failure to Deliver
- Complete Blockage
- Failure to Deliver
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INITIAL MDR WAS FILED OUT OF AN ABUNDANCE OF CAUTION, SO SIRTEX MEDICAL COULD LEARN THE OUTCOME OF THE PATIENT'S RESCHEDULED TREATMENT AND TO INVESTIGATE THE DEVICE FOR THE POTENTIAL OF SERIOUS INJURY AS THE MALFUNCTION CAUSED THE PATIENT'S TREATMENT TO BE RESCHEDULED. SIRTEX MEDICAL HAS LEARNED THAT THE PATIENT WAS SUCCESSFULLY TREATED ON THE RESCHEDULED DATE, 97.3% OF THEIR DOSE WAS ADMINISTERED, AND THAT THE PATIENT DID WELL. SHOULD A PATIENT'S TREATMENT BE RESCHEDULED, SIRTEX MEDICAL AFFAIRS HAS STATED A SHORT PROCEDURAL DELAY OF A FEW DAYS UP TO 1 WEEK WOULD BE UNLIKELY TO CAUSE ANY IMMEDIATE OR CLINICALLY SIGNIFICANT CHANGE TO TUMOR BURDEN IN COMMON CASES. THEY ALSO STATED IT WOULD BE RARE FOR A PATIENT TO BE RESCHEDULED FOR OVER TWO WEEKS. THIS EVENT IS CONSIDERED A MALFUNCTION BECAUSE THE DEVICE COULD NOT PERFORM AS INTENDED HOWEVER THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A CHANGE IN THE PATIENT'S CONDITION THAT WOULD BE CONSIDERED A REPORTABLE SERIOUS INJURY. THE REVIEW OF THE BATCH RECORD DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS AND ALL OPERATIONS WERE COMPLETED PER PROCEDURES. NO DEVIATIONS OR ISSUES ASSOCIATED WITH THE LOT WERE FOUND. SIRTEX HAS MADE MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE FOR FURTHER INVESTIGATION, BUT THE DEVICE HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RECEIVED BY SIRTEX, A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION.
Description of Event or Problem
THE IR EXPERIENCED UNUSUAL RESISTANCE WHEN ATTEMPTING TO DELIVERY THE FIRST ALIQUOT OF THE DOSE. THE DOSE STOPPED AT THE MIDDLE OF THE C-LINE AND WOULD NOT GO ANY FURTHER. AN ATTEMPT TO "UNCLOG" THE DELIVERY SET WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABORT AND RESCHEDULE AS A SECOND DOSE COULD NOT BE DRAWN. IT WAS STATED THAT THE PATIENT WAS FINE.
Additional Manufacturer Narrative
THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.
Description of Event or Problem
THE IR EXPERIENCED UNUSUAL RESISTANCE WHEN ATTEMPTING TO DELIVERY THE FIRST ALIQUOT OF THE DOSE. THE DOSE STOPPED AT THE MIDDLE OF THE C-LINE AND WOULD NOT GO ANY FURTHER. AN ATTEMPT TO "UNCLOG" THE DELIVERY SET WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE DECISION WAS MADE TO ABORT AND RESCHEDULE AS A SECOND DOSE COULD NOT BE DRAWN. IT WAS STATED THAT THE PATIENT WAS FINE.